Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2013 by New York University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gbenga Ogedegbe, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02011685
First received: December 10, 2013
Last updated: December 13, 2013
Last verified: December 2013
  Purpose

This study will assess the comparative effectiveness, cost-effectiveness and sustainability of two telemonitoring interventions in reducing blood pressure and recurrent stroke among 450 high-risk Black and Hispanic stroke patients. The primary hypothesis is that home blood pressure telemonitoring supplemented with individualized, culturally tailored telephone-based nurse case management will have greater effects on blood pressure reduction and stroke recurrence and, while it will be more costly, it will also be more cost-effective than home blood pressure telemonitoring alone. Results of this study will provide strong empirical evidence to inform clinical guidelines and practice, which may lead to reductions in stroke disparities in the United States.


Condition Intervention
Stroke
Hypertension
Behavioral: Home BP Telemonitoring (HBPTM)
Behavioral: Nurse Case Management (NCM)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Practice-Based Trial of Home BP Telemonitoring Among Minority Stroke Survivors

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 12-month systolic blood pressure (SBP) change [ Time Frame: Baseline, 12 months ] [ Designated as safety issue: No ]
  • 24-month stroke recurrence [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-effectiveness for reducing SBP at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Cost-effectiveness for reducing stroke recurrence at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change in other stroke risk factors [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
    lipids, blood glucose

  • Change in health behaviors [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
    diet, physical activity, medication adherence, weight loss

  • Antihypertensive medication intensification [ Time Frame: 6, 12, 24 months ] [ Designated as safety issue: No ]
    adding, changing dose, or changing class of medications


Estimated Enrollment: 450
Study Start Date: December 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Home BP Telemonitoring (HBPTM)
Participants will take home BP readings 3 days per week (morning and evening) for one week out of each month during the 12-month intervention.
Behavioral: Home BP Telemonitoring (HBPTM)
Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.
Experimental: HBPTM + Nurse Case Management (NCM)
Participants will complete the same Home BP Telemonitoring protocol and will also complete 20 counseling phone calls with a nurse case manager during the 12-month intervention.
Behavioral: Home BP Telemonitoring (HBPTM)
Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.
Behavioral: Nurse Case Management (NCM)
Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Black or Hispanic
  • Age 18 years or older
  • English or Spanish speaking
  • Patients who have had an ischemic or hemorrhagic stroke
  • Modified Rankin scale score of ≤ 3
  • Average screening SBP ≥ 140 mm Hg from three BP readings taken at two separate visits with a validated automated device
  • Receiving care at the study site for at least 6 months and planning to continue receiving care at the site for the next two years.

Exclusion Criteria:

  • Being deemed unable to comply with the study protocol (either self-selected or by indicating during screening that he/she could not complete all requested tasks including using the HBPTM or interacting with the NCM if he/she were to be randomized to the intervention group)
  • Participation in other clinical trials
  • Diagnosis of cognitive dysfunction or significant psychiatric comorbidity (as indicated in medical record)
  • Patients with upper arm circumference ≥ 52 cm, the maximum limit of the extra-large BP cuff
  • Diagnosis of dialysis or end stage renal disease
  • Relocating out of area or extended travel during study period
  • Significant verbal speech impairment; unable to participate in intervention telephone sessions
  • Pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02011685

Contacts
Contact: Gbenga Ogedegbe, MD 212-263-4183 olugbenga.ogedegbe@nyumc.org

Locations
United States, New York
NYU School of Medicine Enrolling by invitation
New York, New York, United States, 10016
Sponsors and Collaborators
New York University School of Medicine
  More Information

No publications provided

Responsible Party: Gbenga Ogedegbe, Professor of Population Health and Medicine, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02011685     History of Changes
Other Study ID Numbers: U54NS081765-5162, S13-00281
Study First Received: December 10, 2013
Last Updated: December 13, 2013
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Additional relevant MeSH terms:
Cerebral Infarction
Hypertension
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014